Modular intraocular lens designs, tools and methods

ABSTRACT

Modular IOL systems including a base and a lens, wherein the lens includes fixed and actuatable tabs for connection to the base. The modular IOL allows for the lens to be adjusted or exchanged while leaving the base in place, either intra-operatively or post-operatively. Drug delivery capabilities and/or sensing capabilities may be incorporated into the base. Injector devices may be used to facilitate placement of the base and the lens sequentially or simultaneously into the eye.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/828,083, filed Aug. 17, 2015, entitled “MODULAR INTRAOCULAR LENSDESIGNS, TOOLS AND METHODS,” now U.S. Pat. No. 9,364,316, which claimsthe benefits under 35 U.S.C. §119(e) of priority to U.S. ProvisionalPatent Application No. 62/110,241, filed Jan. 30, 2015, entitled“MODULAR INTRAOCULAR LENS DESIGNS, TOOLS AND METHODS,” each of which isincorporated herein by reference. This application is related to U.S.patent application Ser. No. 14/808,022, filed Jul. 24, 2015, entitled“MODULAR INTRAOCULAR LENS DESIGNS AND METHODS,” which is incorporatedherein by reference. This application also is related to U.S. patentapplication Ser. No. 14/610,360, filed Jan. 30, 2015, entitled “MODULARINTRAOCULAR LENS DESIGNS, TOOLS AND METHODS,” which claims the benefitsunder 35 U.S.C. §119(e) of priority to U.S. Provisional PatentApplication No. 61/941,167, filed Feb. 18, 2014, entitled “MODULARINTRAOCULAR LENS DESIGNS, TOOLS AND METHODS,” each of which isincorporated herein by reference. This application also is related toU.S. patent application Ser. No. 13/969,115, filed Aug. 16, 2013,entitled “MODULAR INTRAOCULAR LENS DESIGNS & METHODS,” now U.S. Pat. No.9,289,287, which claims the benefits under 35 U.S.C. §119(e) of priorityto U.S. Provisional Patent Application No. 61/830,491, filed Jun. 3,2013, entitled “MODULAR INTRAOCULAR LENS DESIGNS AND METHODS,” each ofwhich is incorporated herein by reference. This application also isrelated to U.S. patent application Ser. No. 13/937,761, filed Jul. 9,2013, entitled “MODULAR INTRAOCULAR LENS DESIGNS AND METHODS,” now U.S.Pat. No. 9,125,736, which is incorporated herein by reference. Thisapplication also is related to U.S. patent application Ser. No.13/748,207, filed Jan. 23, 2013, entitled “MODULAR INTRAOCULAR LENSDESIGNS & METHODS,” now U.S. Pat. No. 9,095,424, which claims thebenefits under 35 U.S.C. §119(e) of priority of U.S. Provisional PatentApplication No. 61/589,981, filed on Jan. 24, 2012, entitled “LASERETCHING OF IN SITU INTRAOCULAR LENS AND SUCCESSIVE SECONDARY LENSIMPLANTATION,” and of U.S. Provisional Patent Application No.61/677,213, filed on Jul. 30, 2012, entitled “MODULAR INTRAOCULAR LENSDESIGNS & METHODS,” each of which is incorporated herein by reference.

TECHNICAL FIELD

The present disclosure generally relates to intraocular lenses (IOLs).More specifically, the present disclosure relates to embodiments ofmodular IOL designs, methods and associated tools.

BACKGROUND

The human eye functions to provide vision by transmitting light througha clear outer portion called the cornea, and focusing the image by wayof a crystalline lens onto a retina. The quality of the focused imagedepends on many factors including the size and shape of the eye, and thetransparency of the cornea and the lens.

When age or disease causes the lens to become less transparent (e.g.,cloudy), vision deteriorates because of the diminished light, which canbe transmitted to the retina. This deficiency in the lens of the eye ismedically known as a cataract. An accepted treatment for this conditionis surgical removal of the lens from the capsular bag and placement ofan artificial intraocular lens (IOL) in the capsular bag. In the UnitedStates, the majority of cataractous lenses are removed by a surgicaltechnique called phacoemulsification. During this procedure, an opening(capsulorhexis) is made in the anterior side of the capsular bag and athin phacoemulsification-cutting tip is inserted into the diseased lensand vibrated ultrasonically. The vibrating cutting tip liquefies oremulsifies the lens so that the lens may be aspirated out of thecapsular bag. The diseased lens, once removed, is replaced by an IOL.

After cataract surgery to implant an IOL, the optical result may besuboptimal or may need adjustment over time. For example, shortly afterthe procedure, it may be determined that the refractive correction iserroneous leading to what is sometimes called “refractive surprise.”Also for example, long after the procedure, it may be determined thatthe patient needs or desires a different correction, such as a strongerrefractive correction, an astigmatism correction, or a multifocalcorrection.

In each of these cases, a surgeon may be reluctant to attempt removal ofthe suboptimal IOL from the capsular bag and replacement with a new IOL.In general, manipulation of the capsular bag to remove an IOL risksdamage to the capsular bag including posterior rupture. This riskincreases over time as the capsular bag collapses around the IOL andtissue ingrowth surrounds the haptics of the IOL. Thus, it would bedesirable to be able to correct or modify the optical result without theneed to remove the IOL or manipulate the capsular bag.

Thus, there remains a need for an IOL system and method that allows forcorrection or modification of the optical result using a lens that canbe attached to a base or primary lens without the need to manipulate thecapsular bag.

SUMMARY OF THE DISCLOSURE

Embodiments of the present disclosure provide a modular IOL systemincluding intraocular base and optic components, which, when combined,form a modular IOL. In general, the modular IOL allows for the lens tobe adjusted or exchanged while leaving the base in place, eitherintra-operatively or post-operatively.

In one embodiment, a modular IOL system includes an annular base havingtwo radially outward extending haptics. The base defines a center holeand an inside perimeter, with a radially inward open recess around theinside perimeter. The modular IOL system also includes a lens having anoptical body with first and second tabs extending radially outward fromthe optical body. The base and lens may be assembled with the first andsecond tabs of the lens disposed in the recess of the base. The firsttab may be an actuatable spring, and the second tab may be anon-actuatable extension. The first tab may require radial compressionfor assembly of the lens with the base. The first tab may comprise apair of cantilever springs, each with one end attached the optical bodyand one end free.

Drug delivery capabilities and/or sensing capabilities may beincorporated into the base, which offers several advantages overincorporating such capabilities into the lens. For example, it avoidsany interference the drugs or sensors may have with the opticalperformance of the lens.

Embodiments of the present disclosure also provide injector devices thatfacilitate series or parallel delivery of the base and lens of themodular IOL. The injector may include a barrel having at least oneinternal lumen with at least one plunger disposed therein. After thebase and the lens are both loaded into the barrel, the distal end of thebarrel is placed into the eye and the plunger is advanced in the barrelto place the base and the lens into the eye. The base and the lens maybe placed into the eye sequentially or simultaneously. The barrel mayinclude a single internal lumen with a single plunger disposed therein,two side-by-side internal lumens that merge distally with a plungerdisposed in each lumen, or a single internal lumen with a pair ofco-axial plungers disposed therein, for example. The base and lens maybe placed in the barrel in-line or side-by-side, using cartridges ifdesired.

The modular IOL systems, tools and methods according to embodiments ofthe present disclosure may be applied to a variety of IOL types,including fixed monofocal, multifocal, toric, accommodative, andcombinations thereof. In addition, the modular IOL systems, tools andmethods according to embodiments of the present disclosure may be usedto treat, for example: cataracts, large optical errors in myopic(near-sighted), hyperopic (far-sighted), and astigmatic eyes, ectopialentis, aphakia, pseudophakia, and nuclear sclerosis.

Various other aspects of embodiments of the present disclosure aredescribed in the following detailed description and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate example embodiments of the present disclosure.The drawings are not necessarily to scale, may include similar elementsthat are numbered the same, and may include dimensions (in millimeters)and angles (in degrees) by way of example, not necessarily limitation.In the drawings:

FIG. 1 is a schematic diagram of the human eye shown in cross section;

FIGS. 2A-2F are various views of a modular IOL according to the presentdisclosure;

FIGS. 3A-3F are various views of an alternative base portion of amodular IOL according to the present disclosure;

FIGS. 4A-4G show an example method of how a modular IOL may be implantedand removed;

FIGS. 5A-5D are side schematic views of alternative series or paralleldevices for implanting a modular IOL into the eye;

FIGS. 6A-6C are various views of another alternative base portion of amodular IOL according to the present disclosure;

FIGS. 7A-7C are perspective and top views of an alternative lens portionof a modular IOL according to the present disclosure;

FIGS. 8A and 8B are perspective and top views of another alternativelens portion of a modular IOL according to the present disclosure;

FIG. 9 is a schematic top view of an alternative lens portion of amodular IOL incorporating drug delivery capabilities according to thepresent disclosure; and

FIG. 10 is a schematic top view of an alternative lens portion of amodular IOL incorporating sensor capabilities according to the presentdisclosure.

DETAILED DESCRIPTION

With reference to FIG. 1, the human eye 10 is shown in cross section.The eye 10 has been described as an organ that reacts to light forseveral purposes. As a conscious sense organ, the eye allows vision. Rodand cone cells in the retina 24 allow conscious light perception andvision including color differentiation and the perception of depth. Inaddition, the human eye's non-image-forming photosensitive ganglioncells in the retina 24 receive light signals which affect adjustment ofthe size of the pupil, regulation and suppression of the hormonemelatonin, and entrainment of the body clock.

The eye 10 is not properly a sphere; rather it is a fused two-pieceunit. The smaller frontal unit, more curved, called the cornea 12 islinked to the larger unit called the sclera 14. The corneal segment 12is typically about 8 mm (0.3 in) in radius. The sclera 14 constitutesthe remaining five-sixths; its radius is typically about 12 mm. Thecornea 12 and sclera 14 are connected by a ring called the limbus. Theiris 16, the color of the eye, and its black center, the pupil, are seeninstead of the cornea 12 due to the cornea's 12 transparency. To seeinside the eye 10, an ophthalmoscope is needed, since light is notreflected out. The fundus (area opposite the pupil), which includes themacula 28, shows the characteristic pale optic disk (papilla), wherevessels entering the eye pass across and optic nerve fibers 18 departthe globe.

Thus, the eye 10 is made up of three coats, enclosing three transparentstructures. The outermost layer is composed of the cornea 12 and sclera14. The middle layer consists of the choroid 20, ciliary body 22, andiris 16. The innermost layer is the retina 24, which gets itscirculation from the vessels of the choroid 20 as well as the retinalvessels, which can be seen within an ophthalmoscope. Within these coatsare the aqueous humor, the vitreous body 26, and the flexible lens 30.The aqueous humor is a clear fluid that is contained in two areas: theanterior chamber between the cornea 12 and the iris 16 and the exposedarea of the lens 30; and the posterior chamber, between the iris 16 andthe lens 30. The lens 30 is suspended to the ciliary body 22 by thesuspensory ciliary ligament 32 (Zonule of Zinn), made up of finetransparent fibers. The vitreous body 26 is a clear jelly that is muchlarger than the aqueous humor.

The crystalline lens 30 is a transparent, biconvex structure in the eyethat, along with the cornea 12, helps to refract light to be focused onthe retina 24. The lens 30, by changing its shape, functions to changethe focal distance of the eye so that it can focus on objects at variousdistances, thus allowing a sharp real image of the object of interest tobe formed on the retina 24. This adjustment of the lens 30 is known asaccommodation, and is similar to the focusing of a photographic cameravia movement of its lenses.

The lens has three main parts: the lens capsule, the lens epithelium,and the lens fibers. The lens capsule forms the outermost layer of thelens and the lens fibers form the bulk of the interior of the lens. Thecells of the lens epithelium, located between the lens capsule and theoutermost layer of lens fibers, are found predominantly on the anteriorside of the lens but extend posteriorly just beyond the equator.

The lens capsule is a smooth, transparent basement membrane thatcompletely surrounds the lens. The capsule is elastic and is composed ofcollagen. It is synthesized by the lens epithelium and its maincomponents are Type IV collagen and sulfated glycosaminoglycans (GAGs).The capsule is very elastic and so causes the lens to assume a moreglobular shape when not under the tension of the zonular fibers, whichconnect the lens capsule to the ciliary body 22. The capsule variesbetween approximately 2-28 micrometers in thickness, being thickest nearthe equator and thinnest near the posterior pole. The lens capsule maybe involved with the higher anterior curvature than posterior of thelens.

Various diseases and disorders of the lens 30 may be treated with anIOL. By way of example, not necessarily limitation, a modular IOLaccording to embodiments of the present disclosure may be used to treatcataracts, large optical errors in myopic (near-sighted), hyperopic(far-sighted), and astigmatic eyes, ectopia lentis, aphakia,pseudophakia, and nuclear sclerosis. However, for purposes ofdescription, the modular IOL embodiments of the present disclosure aredescribed with reference to cataracts.

The following detailed description describes various embodiments of amodular IOL system including primary and secondary intraocularcomponents, namely an intraocular base configured to releasably receivean intraocular optic. Features described with reference to any oneembodiment may be applied to and incorporated into other embodiments.

With reference to FIGS. 2A-2F, an embodiment of a modular IOL 90,comprising a base 55 and a lens 65, is shown schematically. FIGS. 2A-2Cshow the base portion 55 of the modular IOL 90, and FIGS. 2D-2F show theoptic or lens portion 65 of the modular IOL 90. Specifically, FIG. 2Ashows a front view of the base 55, FIG. 2B shows a cross-sectional viewtaken along line B-B in FIG. 2A, and FIG. 2C shows a perspective view ofthe base 55. FIG. 2D shows a front view of the lens 65, FIG. 2E shows across-sectional view taken along line E-E in FIG. 2D, and FIG. 2F showsa perspective view of the lens 65. Modular IOL 90 may have dimensions asshown in the drawings by way of example, not necessarily limitation.

With specific reference to FIGS. 2A-2C, the base 55 portion of themodular IOL 20 includes a pair of haptics 54 and a center hole 57 suchthat, except for the outermost portion, the posterior optical surface ofthe lens 65 is not in contact with the base 55 when the lens 65 isattached to the base 55. A recessed groove 92, which is sized andconfigured to receive tab portions 95 and 96 of the lens 65, defines theperimeter of the hole 57.

Recessed groove 92 includes a lower rim 91, an upper rim 93 and aninward-facing lateral wall 94. The upper rim 93 may have an insidediameter that is the same as or greater than the outside diameter of theoptic portion 97 of the lens 65 (excluding tabs 95 and 96) such that thelens 65 can rest inside the hole 57 of the base 55. All or a portion ofthe lower rim 91 may have an inside diameter that is less than theoutside diameter of the lens 65 (including tabs 95 and 96) such that thelower rim 91 acts as a ledge or backstop for the lens 65 when placed inthe hole 57 of the base 55. By way of example, not necessarilylimitation, the upper rim 93 may have an inside diameter of about 6.0mm, the lower rim 91 may have an inside diameter of about 5.5 mm, theoptic portion 97 of lens 65 may have an outside diameter of about 5.8mm, and the tabs 95 and 96 may have a diameter or dimension of about7.125 mm from the apex of tab 95 to the apex of tab 96.

The lower 91 and upper 93 rims defining the groove 92 may extendcontinuously around all or a portion of the perimeter of the hole 57.The base 55 may be cryo-machined in two parts, including lower orposterior portion 55-1 and upper or anterior portion 55-2, that aresubsequently bonded (e.g., adhesive or solvent bond), which may lenditself well to defining a continuous groove 92. To maintain chemical andmechanical property compatibility, the adhesive and the parts 55-1 and55-2 of the base 55 may comprise the same monomeric or polymericformulation. For example, the adhesive may be formulated from the sameacrylic monomers used in making the hydrophobic acrylic parts 55-1 and55-2 of the base 55. Alternatively, the lower 91 and upper 93 rimsdefining the groove 92 may extend discontinuously around all or aportion of the perimeter of the hole 57. An example of a discontinuousarrangement is alternating segments of the lower 91 and upper 93 rims,which may lend itself well to cryo-machining the base 55 in a singlepart. Alternative manufacturing methods well known in the art may alsobe employed.

Optionally, the base posterior portion 55-1 may be a solid disc, ratherthan an annular ring with a hole 57, thereby defining a posteriorsurface against which the posterior side of the lens 65 would contact.The posterior surface may be flat or curved to conform to the posteriorcontour of the lens 65. This may have the advantage of providing abackstop for the lens 65 thereby making delivery and positioning of thelens 65 in the base 55 easier. This may also provide the advantage ofreducing the rate of posterior capsular opacification.

With specific reference to FIGS. 2D-2F, the lens 65 of the modular IOL90 includes an optic portion 97 and one or more tabs 95 and 96. Asshown, tab 95 is fixed, whereas tab 96 may be actuated. As analternative, fixed tab 95 may be replaced with an actuatable tab (e.g.,like tab 96). Fixed tab 95 may include a thru hole 98 so that a probe orsimilar device may be used to engage the hole 98 and manipulate the tab95. Actuatable tab 96 may be actuated between a compressed position fordelivery into the hole 57 of the base 55, and an uncompressed extendedposition (shown) for deployment into the groove 92 of the base 55, thusforming an interlocking connection between the base 55 and the lens 65.

The outside curvature of the fixed tab 95 may have a radius conformingto the inside radius of the groove 92. Similarly, the outside curvatureof the actuatable tab 96 may have a radius that conforms to the insideradius of the groove 92 when the actuatable tab 96 is in itsuncompressed extended position. This arrangement limits relativemovement between the base 55 and the lens 65 once connected.

Optionally, the lens 65 may be oval or ellipsoidal, rather thancircular, with the tabs 95 and 96 positioned adjacent the long axis.This arrangement would thus define a gap between the edge of the lens 65along its short axis and the inside perimeter of the upper rim 93 of thegroove 92 in the base 55. The gap may have the advantage of providingaccess for a probe or similar device to pry apart the lens 65 from thebase 55 if separation were needed.

Actuatable tab 96 may be attached to and extend from the lens 65 at twoends with the middle portion free of the lens 65 (like a leaf spring) asshown. Alternatively, actuatable tab 96 may be attached to and extendfrom the lens 65 at one end with the other end free (like a cantileverspring). Other spring configurations may be employed as known in themechanical arts.

The actuatable tab 96 may elastically deform (e.g., by application of aninward lateral force) to its compressed position. To facilitate lowforce compression, a dimple 99 may be provided on the outside (and/orinside) curvature of the tab to form a hinge in the spring.

FIGS. 3A-3F show an alternative base portion 55A of the modular IOL 90.Specifically, FIG. 3A shows a front view of the base 55A, FIG. 3B showsa cross-sectional view taken along line B-B in FIG. 3A, FIG. 3C shows aperspective view of the base 55A, FIG. 3D shows a detail view of circleD in FIG. 3B, FIG. 3E shows a detail view of circle E in FIG. 3A, andFIG. 3F shows a perspective view of the assembled modular IOL 90including base 55A and lens 65. In this alternative embodiment, allaspects of the base 55A of the modular IOL 90 are substantially the sameexcept for the provision of a pair of cutouts 91A, a pair of notches93A, an outer rim 53, and sharp edges 91B and 91C. All similar aspectsof the prior embodiment are incorporated by reference into thedescription of this embodiment. Also, dimensions are provided by way ofexample, not necessarily limitation.

As in the prior embodiment, the base 55A portion of the modular IOL 90in this alternative embodiment includes a pair of haptics 54 and acenter hole 57 such that, except for the outermost portion, theposterior optical surface of the lens 65 is not in contact with the base55A when the lens 65 is attached to the base 55A. Also as in the priorembodiment, the base 55A may be formed as a single piece, or formed as aposterior portion 55A-1 and an anterior portion 55A-2 that are fixed toeach other by adhesive or the like (as shown). A recessed groove 92,which is sized and configured to receive tab portions 95 and 96 of thelens 65, defines the perimeter of the hole 57. The recessed groove 92includes a lower rim 91, an upper rim 93 and an inward-facing lateralwall 94. The lower rim 91 may be part of the posterior portion 55A-1 ofthe base 55A, and the upper rim may be part of the anterior portion55A-2 of the base 55A

In this alternative embodiment of the base 55A of modular IOL 90, thelower rim 91 may include one or more cutouts 91A, which aid in removingvisco-elastic intra-operatively. Also in this alternative embodiment,the upper rim 93 may include one or more notches 93A to provide accessfor a Sinskey hook intra-operatively, which allows the base 55A to bemore easily manipulated.

Further in this embodiment, the base 55A may include an outer rim 53extending around substantially the entire periphery of the base 55A. Theouter rim 53 may be formed as a part of the posterior portion 55A-1 ofthe base 55A as shown, or as a part of the anterior portion 55A-2 of thebase. At the junction of the haptic 54, the outer rim 53 may terminateshort of the inside curvature of the haptic 54 to provide a flexiblejunction of the haptic 54 to the body of the base 55A, and the outer rim53 may extend continuously with the outside curvature of the haptic 54.

The posterior-most side of base 55A may include at least one corner edge91B along its perimeter, and the outside perimeter of the body of thebase 55A may include corner edges 91C and 91D, all to reduce thetendency for posterior capsular opacification. In addition, an anteriorcorner edge 93B may be formed along the anterior perimeter of the base55A. The corner edges 91B, 91C and 91D may be formed into the posteriorportion 55A-1 of the base 55A defining lower rim 91, and the corner edge93B may be formed into the anterior portion 55A-2 of the base 55Adefining upper rim 93. In cross-section, the corner edges 91B, 91C, 91Dand 93B may be defined by a square angle, an acute angle, or an obtuseangle. The posterior corner edge 91B may be flush with the posteriorsurface as shown, or may protrude posteriorly. The base 55A may bemachined without subsequent tumbling to better form the corner edges91B, 91C, 91D and 93B. Preferably, the corner edges 91B, 91C, 91D and93B may extend around the entire circumference of the base 55A.

Note with reference to FIGS. 2B, 3B and 2E that the lower rim 91 and theupper rim 93 may define an anterior-posterior (AP) dimension around theperimeter of the base 55/55A that is greater than the corresponding APdimension of the lens 65 adjacent the tabs 95 and 96 that fit intogroove 92. For example, the AP dimension of the perimeter of the base55/55A may be 0.615 mm as shown in FIGS. 2B and 3B, and thecorresponding AP dimension of the lens 65 adjacent the tabs 95, 96 maybe 0.25 mm as shown in FIG. 2E. When the modular IOL 90 is implanted inthe capsular bag, these relative dimensions provide a standoff betweenthe posterior capsule and the posterior side of the lens 65, as well asa standoff between the anterior capsule adjacent the capsulorhexis(sometimes call anterior leaflets) and the anterior side of the optic.This standoff reduces the likelihood of cellular proliferation and thepotential for resulting opacification of the lens 65 and/or tissueadhesion to the lens 65 that might otherwise interfere withpost-operative optic exchange. Because such cellular proliferationtypically grows radially inward, the standoff may be provided adjacentthe perimeter of the lens 65 adjacent the inside circumference of thelower and upper rims 91, 93, whereas the center of the optic may or maynot have a standoff, with an AP dimension that is less than, the same asor greater than the AP dimension around the perimeter of the base55/55A. For example, the center of the optic may have an AP dimension of0.78 mm as shown in FIG. 2E (depending on the diopter), which is greaterthan the AP dimension of the perimeter of the base 55/55A at 0.615 mm asshown in FIGS. 2B and 3B. Additionally, the lower (posterior) rim 91 mayhave a greater AP dimension than the upper (anterior) rim 93 recognizingthe cellular proliferation may be more likely on the posterior side thanthe anterior side due to the presence of the capsulorhexis on theanterior side and the corresponding lower tissue contact area on theanterior side. Those skilled in the art will recognize the importance ofthe relative dimensions to achieve this effect rather than the specificdimensions, which are provided by way of example, not necessarilylimitation.

By way of example, not necessarily limitation, the following dimensionsare provided with reference to alternative base 55A illustrated in FIGS.3A-3E. In FIG. 3A, diameter A1 may be 13.00±0.02 mm, diameter A2 may be8.50±0.10 mm, diameter A3 may be 7.00±0.051 mm, diameter A4 may be6.30±0.051 mm, diameter A5 may be 5.50±0.15/−0.05 mm, and diameter A6may be 7.92 mm. In FIG. 3B, dimension B1 may be 0.615±0.020 mm. In FIG.3D, dimension D1 may be 0.15 mm, dimension D2 may be 0.17 mm, dimensionD3 may be 0.75 mm, dimension D4 may be 0.35 mm, dimension D5 may be 0.08mm, and dimension D6 may be 0.30±0.02 mm. In FIG. 3E, dimension E1(width of cutouts 91A) may be 1.48 mm, dimension E2 (diameter at outeredge of notches 93A) may be 6.62 mm, dimension E3 (inside diameter ofupper rim 93) may be 6.25 mm, and dimension E4 (radian of cutouts 91A)may be 30 degrees.

In general, the modular IOL 90 allows for the lens 65 to be adjusted orexchanged while leaving the base 55 in place, either intra-operativelyor post-operatively. Examples of instances where this may be desirableinclude, without limitation: exchanging the lens 65 for a suboptimalrefractive result detected intra-operatively; exchanging the lens 65 fora suboptimal refractive result detected post-operatively (residualrefractive error); rotationally adjusting the lens 65 relative to thebase 55 to fine tune toric correction; laterally adjusting the lens 65relative to the base 55 for alignment of the optic with the true opticalaxis (which may not be the center of the capsular bag); and exchangingthe lens 65 for the changing optical needs or desires of the patientover longer periods of time. Examples of the latter instance include,but are not limited to: an adult or pediatric IOL patient whose originaloptical correction needs to be changed as s/he matures; a patient whowants to upgrade from a monofocal IOL to a premium IOL (toric,multifocal, accommodating or other future lens technology); a patientwho is not satisfied with their premium IOL and wants to downgrade tomonofocal IOL; and a patient who develops a medical condition where anIOL or a particular type of IOL is contra-indicated.

An example of how the modular IOL 90, including base 55 and lens 65, maybe implanted is shown in FIGS. 4A-4D. An example of how the lens 65 maybe removed from the base 55 is shown in FIGS. 4E-4G. After the lens 65is removed from the base 55 (and the eye), a different lens 65 may beimplanted in the same base 55 following the steps described withreference to FIGS. 4C-4D.

As shown in FIG. 4A, the modular IOL 90 may be implanted by initiallydelivering the base 55 into the capsular bag in a rolled configurationusing an injector (a.k.a., inserter or delivery tube) inserted through acorneal incision 13, through the capsulorhexis 36, and into the capsularbag 34. As shown in FIG. 4B, the base 55 may be ejected from theinjector and allowed to unfurl. With gentle manipulation, the haptics 54of the base 55 engage the inside equator of the lens capsule 34 andcenter the hole 57 of the base 55 relative to the capsulorhexis 36.

The lens 65 may also be delivered in a rolled configuration using aninjector, positioning the distal tip thereof adjacent the base 55. Thelens 65 may be ejected from the injector and allowed to unfurl. Withgentle manipulation, the lens 65 is centered relative to thecapsulorhexis 36. Once the base 55 has been delivered and unfurled inthe capsular bag, the lens 65 may be connected to the base 55 viaplacing tabs 95 and 96 into groove 92 to provide an interlockingconnection between the base 55 and the lens 65.

As shown in FIGS. 4C-4D, the lens 65 may be connected to the base 55 byfirst inserting the actuatable tab 96 into the groove 92. The actuatabletab 96 may then be compressed by application of a lateral force using aprobe or similar device inserted into hole 98 of fixed tab 95, allowingthe lens 65 to be advanced into the hole 57 of the base 55 such that thelens 65 and base 55 are coplanar.

The compressive force may then be released from the actuatable tab 96,allowing the fixed tab 95 to slide into the groove 92 of the base 55,thus connecting the lens 65 to the base 55. By using a lateral force tocompress the interlocking feature rather than an anterior-posteriorforce, the risk of posterior rupture of the capsular bag is reduced. Theprobe may be removed from hole 98. Reverse steps may be followed todisconnect the lens 65 from the base 55.

The actuatable tab 96 and groove 92 may be described as interlockingmembers that provide an interlocking connection between the base 55 andthe lens 65, wherein at least one of the pair of interlocking members isactuatable to lock or unlock the connection therebetween. Moregenerally, one or more interlocking connections may be provided betweenthe base and lens. Each interlocking connection may include a pair ofinterlocking members, wherein one or both of the interlocking membersare actuatable. The actuatable interlocking member may be associatedwith the lens as described with reference to modular IOL 90 in FIGS.2A-2F.

As shown in FIGS. 4E-4G, lens removal begins by disengaging a lens 65from a base 55. As shown in FIG. 4E, a probe or similar device may passthrough the corneal incision 13, capsulorhexis 36, and enter thecapsular bag 34 containing a modular IOL, for example modular IOL 90. Asshown in FIG. 4F, the probe or similar device may engage the hole 98 offixed tab 95 and compress the actuatable tab 96 by application of alateral force. Upon compression, fixed tab 95 may separate from groove92 of the base 55. With gentle manipulation, the lens 65 may be liftedsuch that the lens 65 and base 55 are no longer coplanar. Once freed,the compressive force may then be released and the actuatable tab 96 mayelastically expand and separate from the groove 92 of the base 55.

As shown in FIG. 4G, the probe or similar device may be used to pass thelens 65 from the capsular bag 34 into the anterior chamber 15. This stepdoes not damage the eye or expand the size of the capsulorhexis 36because the width of the lens 65 is less than the width of thecapsulorhexis 36. The probe or similar device may also rotate the lens65 into an orientation where the fixed tab 95 is proximal to the cornealincision 13 and the actuatable tab 96 is distal to the corneal incision13.

A typical corneal incision 13 may have a width of about 2.2 mm, lessthan the outer diameter of the lens 65. Removing the lens 65 from theanterior chamber 15 through the corneal incision 13 may thus requiremechanical manipulation of the lens 65. The lens 65 may be manipulated,for example cut, such that it can be pulled through the cornealincision, either as a single piece or in multiple pieces. A cannula ortube may be used to facilitate this removal.

A conventional injector (a.k.a., inserter) may be used to deliver thebase 55 and lens 65. Examples of suitable injectors are described inU.S. Pat. No. 5,123,905 to Kelman, U.S. Pat. No. 4,681,102 to Bartell,U.S. Pat. No. 5,304,182 to Rheinish, and U.S. Pat. No. 5,944,725 toCicenas. Such injectors may be configured to deliver the base 55 andlens 65 singly as described with reference to FIGS. 4A-4G.Alternatively, the base 55 and lens 65 may be loaded into an injectorin-line for delivery in series (i.e., sequentially) or loadedpre-assembled for delivery in parallel (i.e., simultaneously). Examplesof alternative injector configurations that facilitate series orparallel delivery are shown in FIGS. 5A-5D.

With reference to FIG. 5A, alternative injector 100 includes a tubularbarrel 102 having a single internal lumen with a plunger 104 disposedtherein. The distal end 106 of the barrel 102 is tapered for insertioninto a corneal incision. A pair of in-line cartridges 108A and 108B aredisposed in the barrel 102 and are configured to hold the base 55 andlens 65, respectively, in a rolled configuration (not visible).Cartridges 108A and 108B may be configured as disclosed in Bartell '102mentioned above, except that two in-line cartridges are provided insteadof one. As an alternative to cartridges 108A and 108B, the base 55 andlens 65 may be pre-disposed in the barrel 102 or placed in the barrel102 through a side-load opening as described by Kelman '905 mentionedabove. Optionally, a spacer 107 may be disposed between the cartridges108A and 108B inside the barrel 102. Upon advancement of the plunger 104inside the barrel 102, the distal end of the plunger 104 pushes the lens65 out of cartridge 108B which, in turn, pushes the spacer 107 (if used)to engage the base 55 disposed in cartridge 108A. Continued advancementof the plunger 104 pushes the base 55 out of the distal end 106 of theinjector 100 and into the eye, followed by the lens 65. The lens 65 maythen be attached to the base 55 inside the eye. The spacer 107 may betethered to the injector to avoid implantation in the eye, or it may beformed of a dissolvable material that can be left in the eye. The base55 may have a lower volume than lens 65 (i.e., less material) such thatthe force required to advance the base 55 in the barrel 102 is lowerthan the force required to advance the lens 65 in the barrel 102, thusreducing the tendency of the lens 65 to jam inside the barrel 102 as itpushes against the base 55.

With reference to FIG. 5B, another alternative injector 110 includes atubular barrel 102 having two side-by-side internal lumens separated byinternal wall 103, with a pair of plungers 104A and 104B disposedtherein. The distal end 106 of the barrel 102 includes a common singlelumen where the two side-by-side lumens merge and the wall 103terminates. The distal end 106 of the barrel 102 is tapered forinsertion into a corneal incision. A pair of side-by-side cartridges108A and 108B are disposed in the barrel 102 and are configured to holdthe base 55 and lens 65, respectively, in a rolled configuration (notvisible) in each of the side-by-side lumens. Cartridges 108A and 108Bmay be configured as disclosed in Bartell '102 mentioned above, exceptthat two side-by-side cartridges are provided instead of one. As analternative to cartridges 108A and 108B, the base 55 and lens 65 may bepre-disposed in the barrel 102 or placed in the barrel 102 throughside-load openings as described by Kelman '905 mentioned above. Uponadvancement of the plunger 104A inside the barrel 102, the distal end ofthe plunger 104A pushes the base 55 out of cartridge 108A, out of thedistal end 106 of the injector 100 and into the eye. Plunger 104A maythen be retracted into its original position. Subsequently, plunger 104Bmay be advanced inside the barrel 102 to push the lens 65 out ofcartridge 108B, out of the distal end 106 of the injector 100 and intothe eye. The lens 65 may then be attached to the base 55 inside the eye.

With reference to FIG. 5C, another alternative injector 120 includes atubular barrel 102 having a single internal lumen with a pair ofco-axial plungers 104C and 104D disposed therein. The inner plunger 104Cis configured to be axially movable inside outer tubular plunger 104D.The distal end 106 of the barrel 102 is tapered for insertion into acorneal incision. A pair of in-line cartridges 108A and 108B aredisposed in the barrel 102 and are configured to hold the base 55 andlens 65, respectively, in a rolled configuration (not visible).Cartridges 108A and 108B may be configured as disclosed in Bartell '102mentioned above, except that two in-line cartridges are provided insteadof one. As an alternative to cartridges 108A and 108B, the base 55 andlens 65 may be pre-disposed in the barrel 102 or placed in the barrel102 through a side-load opening as described by Kelman '905 mentionedabove. The lens 65 may be rolled about the shaft of the inner plunger104C allowing the inner plunger 104C to slide therethrough. Uponadvancement of the inner plunger 104C inside the outer plunger 104D andbarrel 102, the distal end of the inner plunger 104C pushes the base 55out of cartridge 108A. Continued advancement of the inner plunger 104Ccauses the distal end thereof to push the base 55 out of the distal end106 of the injector 100 and into the eye. The inner plunger 104C maythen be retracted to its original position. Upon subsequent advancementof the outer plunger 104D over the inner plunger 104C, the distal end ofthe outer plunger 104D pushes the lens 65 out of the cartridge 108B.Continued advancement of the outer plunger 104D pushes the lens 65 offthe distal end of the inner plunger 104C, out of the distal end 106 ofthe injector 100 and into the eye. The lens 65 may then be attached tothe base 55 inside the eye.

With reference to FIG. 5D, another alternative injector 130 includes atubular barrel 102 having a single internal lumen with a plunger 104disposed therein. The distal end 106 of the barrel 102 is tapered forinsertion into a corneal incision. A pair of side-by-side cartridges108A and 108B are disposed in lateral slot extensions 109A and 109B,respectively. Cartridges 108A and 108B and are configured to hold thebase 55 and lens 65, respectively, in a rolled configuration (notvisible). Cartridges 108A and 108B may be configured as disclosed inBartell '102 mentioned above, except that two side-by-side cartridgesare provided instead of one. As an alternative to cartridges 108A and108B, the base 55 and lens 65 may be pre-disposed in the barrel 102 orplaced in the barrel 102 through side-load openings as described byKelman '905 mentioned above.

With continued reference to FIG. 5D, the side-by-side cartridges 108Aand 1086 slide laterally inside the slot extensions 109A and 1096 toalign the base 55 contained in cartridge 108A with the lumen of thebarrel 102 when pushed in a first position (down position as shown), andto align the lens 65 contained in cartridge 1086 with the lumen of thebarrel 102 when pushed into a second position (up position, not shown).Initially, cartridge 108A containing base 55 is pushed into the slotextension 109A and into the barrel 102. Upon advancement of the plunger104 inside the barrel 102, the distal end of the plunger 104 pushes thebase 55 out of cartridge 108A, out of the distal end 106 of the injector100 and into the eye. Plunger 104 may then be retracted into itsoriginal position (as shown). Subsequently, cartridge 108B is pushedinto slot extension 109B and into the barrel 102, pushing emptycartridge 108A out of the barrel 102 and into slot extension 109A.Plunger 104 may then be advanced inside the barrel 102 to push the lens65 out of cartridge 1086, out of the distal end 106 of the injector 100and into the eye. The lens 65 may then be attached to the base 55 insidethe eye. The cartridges 108A and 108B may be slid manually as describedor may be automatically moved, for example, using a spring to bias topush cartridge 1086 containing lens 65 into the barrel 102 when theplunger 104 is retracted after delivering the base 55 from cartridge108A.

As mentioned previously, the base 55 and lens 65 may be delivered inseries or in parallel. For delivery in parallel, the lens 65 may bepre-assembled with the base 55, rolled together, and then loaded into aninjector for delivery into the eye, thus negating the need to assemblethe two inside the eye. A dissolvable adhesive, a severable member(e.g., a tab, tether or hinge severable by cutting or laser ablating) orother temporary connecting means may be used to maintain the assembledconnection between the base 55 and lens 65 during the rolling, loadingand delivery process. Alternatively, the lens 65 may be stacked onto thebase 55 (without assembling the two), rolled together, loaded into aninjector, delivered into the eye, and then assembled inside the eye.

FIGS. 6A-6C illustrate another alternative base 55B for use with themodular IOL 90. FIG. 6A is a perspective view of the base 55B, FIG. 6Bis a top (anterior) view of the base 55B, and FIG. 6C is a perspectivesectional view of the base 55B taken along line C-C in FIG. 6B.Alternative base 55B is similar to base 55 except for the configurationof the groove 92 and the overall size of the base 55B. All similaraspects of the prior embodiment are incorporated by reference into thedescription of this embodiment.

In this embodiment, the groove 92 is defined by an upper rim or wall 93angled in an anterior direction, an inward-facing lateral wall 94, and alower rim or wall 91 angled in a posterior direction. The upper rim 93may be angled at 30 degrees, for example, anteriorly from the plane ofthe groove 92, and the lower rim 91 may be angled at 30 degrees, forexample, posteriorly from the plane of the groove 92.

The lateral wall 94 may have a height (anterior-posterior dimension)that matches the thickness of the tabs 95 and 96. The lateral wall 94may have a linear geometry that matches the outer-most wall of the tabs95 and 96. The lateral wall 94 may intersect the upper and lower rims 93and 91 to form inside corners. Compared to a curved intersection, theinside corners may provide better anterior-posterior stability of thetabs 95 and 96 inside the groove 92, and thereby provide betteranterior-posterior stability of the lens 65 relative to the base 55B.

The opening of the groove 92 may have a dimension defined by thedistance between the upper rim 93 and the lower rim 91 along the insidediameter of the rims 91 and 93. The opening dimension of the groove 92may be substantially greater than the thickness of the tabs 95 and 96 toallow for easy insertion of the lens 65 into the base 55B. In oneexample, the opening dimension of the groove 92 is 1.5 times greaterthan the thickness of the tabs 95 and 96. In another example, theopening dimension of the groove 92 is 2.0 times greater than thethickness of the tabs 95 and 96. The large opening of the groove 92allows for faster and easier insertion of the lens 65 into the base 55B.

Commercially available IOLs typically have an equatorial diameter(excluding haptics) of about 6 mm, an anterior-posterior thickness ofabout 0.2 mm at 6 mm diameter and 0.7 mm at the center, providing anoverall volume of about 12 mm³. Lens 65 is similarly dimensioned, butthe base 55B adds substantially more volume. The base 55B may have anequatorial diameter (excluding haptics 54) of about 8.5 mm, ananterior-posterior thickness of about 1 mm at 8.5 mm diameter, 2.5 mm at6 mm diameter, providing an overall volume of about 67 mm³ when the lens65 is disposed in the base 55B. Thus, the size of the combined base 55Band lens 65 is volumetrically much larger than conventional IOLsavailable on the market. This relatively larger volume is intended tofill the capsular bag more like a natural lens, thus increasing thestability of the base 55B and reducing post-operative migration due tothe bag collapsing around the base 55B. By way of comparison, a typicalnatural lens has an equatorial diameter of about 10.4 mm, ananterior-posterior dimension of about 4.0 mm for a corresponding volumeof about 180 mm³. Due to anatomic variability, a natural lens may have avolume ranging from 130 mm³ to 250 mm³. Thus, the base 55B plus the lens65 consumes about 50% to 25% of the volume of the bag after the naturallens has been extricated, whereas a conventional IOL consumes about 10%to 5% of the volume of the bag.

FIGS. 7A-7B illustrate an alternative lens 65A for use with the modularIOL 90. FIG. 7A is a perspective view of the alternative lens 65A, andFIG. 7B is a top (anterior) view of the lens 65A. Alternative lens 65Ais similar in design and function as lens 65, except for a notch 98Aprovided in the fixed tab 95 and an alternative actuatable tab 96A. Allsimilar aspects of the prior embodiment are incorporated by referenceinto the description of this embodiment.

Specifically, alternative lens 65A includes an optic portion 97 and oneor more fixed tabs 95 and one or more actuatable tabs 96A. Optionally,fixed tab 95 may be replaced with an actuatable tab (e.g., like tab96A). Fixed tab 95 may include a thru hole 98 so that a probe or similardevice may be used to engage the hole 98 and manipulate the tab 95.Fixed tab 95 may also include a notch 98A positioned counter-clockwiseof the hole 98 (or otherwise on the counter-clockwise side of the tab95) to provide an indication that the anterior side of the lens 65A isright side up when implanted. In other words, when the lens 65A isplaced in the base 55, if the notch 98A is positioned counter-clockwiseof the hole 98, then the anterior side of the lens 65A is correctlypositioned facing anteriorly. If the notch 98A is positioned clockwiseof the hole 98, then the anterior side of the lens 65A is incorrectlypositioned facing posteriorly. Other indicators of correctanterior-posterior placement of the lens 65A may be employed byproviding two markers about the periphery of the lens 65A anddesignating their correct relative position (clockwise orcounter-clockwise).

Actuatable tab 96A may be actuated between a compressed position fordelivery into the hole 57 of the base 55, and an uncompressed extendedposition (shown) for deployment into the groove 92 of the base 55, thusforming an interlocking connection between the base 55 and the lens 65A.Actuatable tab 96A includes two members 96A1 and 96A2, each with one endconnected to the peripheral rim 97A around optic 97, and the other endfree, thus forming two cantilever springs. Compared to actuatable tab 96(illustrated in FIGS. 2D-2F) which is attached at two ends to theperiphery of the optic 97 and is joined in the middle like a single leafspring, actuatable tab 96A includes two members 96A1 and 96A2 with eachend attached to the peripheral rim 97A around the optic 97 and the otherend free like two cantilever springs. A notch 96A3 may be formed in theperipheral rim 97A between the two members 96A1 and 96A2 to addhinge-like flexibility to the two members 96A1 and 96A2 where theyattach to the peripheral rim 97A. Notch 96A3 also provides access for aprobe or similar device manipulate the tab 96A into the groove 92 in thebase 55.

As shown in FIGS. 7A and 7B, the two cantilever members 96A1 and 96A2 ofactuatable tab 96A are attached at one end to the peripheral rim 97Aaround the optic 97 and extend radially outward and away from each otherin an arc shape. In this configuration, and as compared to actuatabletab 96 shown in FIGS. 2D-2F, the cantilever members 96A1 and 96A2 engagethe lateral wall 94 defining the groove 92 in the base 55 at twospaced-apart portions. Together with fixed tab 95, which contacts aportion of the lateral wall 94 diametrically opposite, the lens 65A isconnected to the base 55 at three spaced apart locations, thus providingadditional relative planar stability.

Optionally, one or both of the two cantilever members 96A1 and 96A2 mayinclude a hole 96A4 as shown in FIG. 7C. Hole 96A4 may be sized andconfigured to receive an intraocular tool such as a Sinskey hook, whichmay be used to rotate the lens 65A when disposed in the base 55. Thisallows for easy rotational adjustment of the lens 65A relative to thebase 55, which may be useful in making adjustments in toricapplications. Such a feature may be incorporated into any of the fixedor actuatable tabs described herein.

FIGS. 8A-8B illustrate yet another alternative lens 65B for use with themodular IOL 90. FIG. 8A is a perspective view of the lens 65B, and FIG.8B is a top (anterior) view of the lens 65B. Alternative lens 65B issimilar in design and function as lens 65A, except for an alternativeactuatable tab 96B, which includes two cantilever members 96B1 and 96B2.All similar aspects of the prior embodiment are incorporated byreference into the description of this embodiment. In this embodiment,the two cantilever members 96B1 and 96B2 of actuatable tab 96B areattached at one end to the peripheral rim 97A around the optic 97 andextend radially outward and toward each other (rather than away fromeach other) in an arc shape. This configuration is similar to theactuatable tab 96 shown in FIGS. 2D-2F except that the members 96B1 and96B2 are disconnected, thus forming a pair of cantilever springs ratherthan a leaf spring.

Optionally, drugs may be incorporated into or carried by the base 55.Using the base 55 as a carrier for drugs, as opposed to the lens 65, hasa number of advantages. For example, it avoids any interference the drugor drugs may have with the optical performance of the lens 65. Also,because the base 55 doesn't require tumbling as part of themanufacturing process like the lens 65 does, drugs carried by the base55 aren't exposed to potential damage. Drugs may be incorporated intothe base 55 by connecting one or more separate drug carriers to the base55, having the material of the base 55 act as a carrier for the drug(e.g., like a sponge), incorporating one or more drug-eluting materialsinto the base 55, or incorporating one or more refillable reservoirsinto the base 55 that carry the drug. One or multiple portions of thebase 55 may carry the drug or drugs, and these portions may be separatefrom each other, to avoid interaction between different drugs, forexample. The portion or portions of the base 55 carrying the drug may beselectively activated by light or thermal energy (e.g., laser, UV light,etc.) to release the stored drug or drugs all at once or in a series ofreleases over time.

Examples of clinical indications for such drugs include wet or drymacular degeneration, open or close angle glaucoma, uveitis, posteriorcapsular opacification, post-op management after cataract surgery, etc.Examples of drugs that may be used for wet macular degeneration includeaflibercept, bevacizumab, pegaptanib, ranibizumab, steroids, andaptamers. Examples of drugs that may be used for dry maculardegeneration include complement factors, anti-oxidants andanti-inflammatory agents. Examples of drugs that may be used for openangle glaucoma include brimonidine, latanoprost, timolol, pilocarpine,brinzolamide and other drugs in the general categories of beta blockers,alpha agonists, ROCK Inhibitors, adenosine receptor agonsists, carbonicanhydrase inhibitors, adrenergic and cholinergic receptor activatingagents, and prostaglandin analogues. Examples of drugs that may be usedfor uveitis include methotrexate, antibodies, dexamethasone,triamcinolone, and other steroid agents. Examples of drugs that may beused for posterior capsular opacification include anti-proliferative,anti-mitotic, anti-inflammatory, and other medications that wouldinhibit the spread of lens epithelial cells. Examples of drugs that maybe used for post-op management after cataract surgery includeantibiotics such as fluoroquinolones, non-steroidal agents such asketorolacs, and steroids such as prednisolones. Other medications thatmay be used to treat various ocular diseases and conditions include:anti-fibrotic agents, antiinflammatory agents, immunosuppressant agents,anti-neoplastic agents, migration inhibitors, anti-proliferative agents,rapamycin, triamcinolone acetonide, everolimus, tacrolimus, paclitaxel,actinomycin, azathioprine, dexamethasone, cyclosporine, bevacizumab,anti-VEGF agents, anti-IL-1 agents, canakinumab, anti-IL-2 agents, viralvectors, beta blockers, alpha agonists, muscarinic agents, steroids,antibiotics, non-steroidal antiinflammatory agents, prostaglandinanalogues, ROCK inhibitors, nitric oxide, endothelin,matrixmetalloproteinase inhibitors, CNPA, corticosteroids, andantibody-based immunosuppresants. These drugs may be used individuallyor in combination, depending on the patient's particular clinicalindication.

Also, the portion or portions of the base 55 carrying the drug or drugsmay face a particular direction or directions while other directions aremasked or blocked to increase the concentration of the drug on aspecific portion of the lens capsule. For example, posterior ocularstructures may be the focus of drug delivery (e.g., to mitigate maculardegeneration), and/or anterior ocular structures may be the focus ofdrug delivery (e.g., to deliver glaucoma drugs adjacent the angle, todeliver drugs for uveitis or post-op management after cataract surgery).

By way of example, FIG. 9 shows a top (anterior) view of the base 55,which incorporates one or more drug carriers 50. As shown, the drugcarriers 50 are spaced around the circumference of the anterior side ofthe body of the base 55. The drug carriers 50 may comprise a refillablereservoir (e.g., silicone vessel), an eluting porous material (e.g.,biocompatible sponge), a biodegradable or bioerodable material (e.g.,PLGA), etc. The reservoir may also be targeted to expose drugs to theaqueous environment through laser, UV light, RF signal, magneticmanipulation or other methods for remotely removing a barrier todiffusion. The carriers 50 may be placed on the surface of the base 55,or embedded, for example. To focus the delivery of drugs to a particulararea of the eye, the carriers 50 may be exposed on one side (e.g., theanterior side as shown) while the material of the base 55 covers theother sides.

Similarly, one or more microelectronic sensors may be incorporated intoor carried by the base 55. Using the base 55 as a carrier for sensors,as opposed to the lens 65, has a number of advantages. For example, itavoids any interference the sensors may have with the opticalperformance of the lens 65. Also, because the base 55 doesn't requiretumbling as part of the manufacturing process like the lens 65 does,sensors carried by the base 55 aren't exposed to potential damage.

As shown in FIG. 10 which is a top (anterior) view of a base 55, asensor 70 may be attached or embedded in the base 55 in a manner similarto drug carrier 50 described with reference to FIG. 9. The sensor 70 maybe connected to an integrated control circuit 72, which is connected toan antenna 74. The control circuit 72 may include a transmitter ortransceiver circuit to wirelessly transmit sensor data to an externaldevice via antenna 74. The control circuit 72 may include a powercircuit that receives electrical power via an inductive link to anexternal power source. Examples of suitable sensors that may beincorporated into or carried by the base 55 include biological sensorssuch as a glucose sensor, an electrolyte sensor, a protein sensor, atemperature sensor, a conductivity sensor, an electric field sensor, apressure sensor (e.g., for measuring intra-ocular pressure), a pulseoximeter sensor, or a photo sensor to support artificial vision.Examples of microelectronic sensors for use with contact lenses aredescribed in U.S. Patent Application Publications 2014/0085599,2014/0084489, 2014/0085602, and 2014/0087452, 2014/0085600,2014/0088381, 2014/0192311, 2014/0194710, 2014/0194713, 2014/0194773,2014/0098226 and 20140081178, and PCT Publication WO/2014/204575 whichare incorporated herein by reference. Such microelectronic sensors foruse with contact lenses may be hermetically sealed in the base 55 forimplant applications in the eye. The sensor 70 may include a permeablecover for direct biological interface applications (glucose sensor,electrolyte sensor, protein sensor, etc.). Alternatively, the sensor 70may include an impermeable cover for indirect biological interfaceapplications (pressure sensor, temperature sensor, conductivity sensor,electric field sensor, etc.).

The foregoing discussion of the disclosure has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the disclosure to the form or forms disclosed herein. Althoughthe disclosure has included description of one or more embodiments andcertain variations and modifications, other variations and modificationsare within the scope of the disclosure, e.g., as may be within the skilland knowledge of those in the art, after understanding the presentdisclosure. It is intended to obtain rights which include alternativeembodiments to the extent permitted, including alternate,interchangeable and/or equivalent structures, functions, ranges or stepsto those claimed, whether or not such alternate, interchangeable and/orequivalent structures, functions, ranges or steps are disclosed herein,and without intending to publicly dedicate any patentable subjectmatter.

We claim:
 1. A method of implanting an intra-ocular lens (IOL) in an eyehaving a capsular bag with an internal volume, the method comprising:positioning the IOL in the capsular bag, the IOL including: an optichaving a central visual axis and a central thickness along the centralvisual axis, and an annular ring surrounding the optic, the annular ringincluding: a periphery, a first rim surrounding the optic, and a secondrim surrounding the optic and disposed opposite the first rim, the firstrim and the second rim flaring outwardly toward the central visual axisfrom the periphery, the first rim and the second rim establishing ananterior-posterior thickness of the annular ring that is greater thanthe central thickness of the optic, wherein positioning the IOL in thecapsular bag includes orienting the first rim anteriorly and the secondrim posteriorly in the eye; and filling between about 25% to about 50%of the volume of the capsular bag with the IOL.
 2. The method of claim1, further including engaging the capsular bag with one or more hapticsextending from the periphery of the annular ring.
 3. The method of claim1, wherein the annular ring and the optic are discrete components andwherein positioning the IOL in the capsular bag includes assembling theoptic to the annular ring.
 4. The method of claim 1, wherein the IOLfurther includes a recess extending between the first rim and ananterior surface of the optic.
 5. The method of claim 4, wherein therecess tapers toward the periphery of the annular ring.
 6. The method ofclaim 1, wherein an inside diameter of the second rim is less than aninside diameter of the first rim.
 7. The method of claim 1, wherein thefirst rim includes an inner posterior edge, the second rim includes aninner anterior edge, and a distance between the inner posterior edge andthe inner anterior edge is about 1.5 to about 2 times greater than ananterior-posterior thickness of the optic at a periphery of the optic.8. The method of claim 1, wherein an inner anterior-posterior thicknessof the annular ring is at least twice as large as an outeranterior-posterior thickness of the annular ring.
 9. A method ofimplanting an intra-ocular lens (IOL) in an eye having a capsular bagwith an internal volume, the method comprising: positioning the IOL inthe capsular bag, the IOL including: an optic having a central visualaxis and a central thickness along the central visual axis, and anannular ring surrounding the optic, the annular ring including: aperiphery, a first rim surrounding the optic, and a second rimsurrounding the optic and disposed opposite the first rim, the first rimand the second rim flaring outwardly toward the central visual axis fromthe periphery, the first rim and the second rim establishing ananterior-posterior thickness of the annular ring that is greater thanthe central thickness of the optic, wherein positioning the IOL in thecapsular bag includes orienting the first rim anteriorly and the secondrim posteriorly in the eye, and wherein positioning the IOL in thecapsular bag includes assembling the optic to the annular ring.
 10. Themethod of claim 9, further including engaging the capsular bag with oneor more haptics extending from the periphery of the annular ring. 11.The method of claim 9, further comprising filling between about 25% toabout 50% of the volume of the capsular bag with the IOL.
 12. The methodof claim 9, wherein the IOL further includes a recess extending betweenthe first rim and an anterior surface of the optic.
 13. The method ofclaim 12, wherein the recess tapers toward the periphery of the annularring.
 14. The method of claim 9, wherein an inside diameter of thesecond rim is less than an inside diameter of the first rim.
 15. Themethod of claim 9, wherein the first rim includes an inner posterioredge, the second rim includes an inner anterior edge, and a distancebetween the inner posterior edge and the inner anterior edge is about1.5 to about 2 times greater than an anterior-posterior thickness of theoptic at a periphery of the optic.
 16. The method of claim 9, wherein aninner anterior-posterior thickness of the annular ring is at least twiceas large as an outer anterior-posterior thickness of the annular ring.17. A method of implanting an intra-ocular lens (IOL) in an eye having acapsular bag with an internal volume, the method comprising: positioningthe IOL in the capsular bag, the IOL including: an optic having acentral visual axis and a central thickness along the central visualaxis, and an annular ring surrounding the optic, the annular ringincluding: a central longitudinal axis, an first angled rim surroundingthe optic, a second angled rim surrounding the optic, the first angledrim and the second angled rim establishing a thickness of the annularring, the annular ring having a first anterior-posterior thickness at afirst distance from the central longitudinal axis, and the annular ringhaving a second anterior-posterior thickness at a second distance fromthe central longitudinal axis, the second distance being greater thanthe first distance, the first anterior-posterior thickness being greaterthan the second anterior-posterior thickness, and the firstanterior-posterior thickness being greater than the central thickness ofthe optic; and filling between about 25% and about 50% of a volume ofthe capsular bag with the IOL.
 18. The method of claim 17, whereinorienting the IOL in the capsular bag includes orienting the firstangled rim anteriorly, and orienting the second angled rim posteriorly.19. The method of claim 17, wherein the annular ring and the optic arediscrete components and wherein positioning the IOL in the capsular bagincludes assembling the optic to the annular ring.
 20. The method ofclaim 17, further including engaging the capsular bag with one or morehaptics extending from a periphery of the annular ring.
 21. The methodof claim 17, wherein the first angled rim is angled anteriorly towardthe central longitudinal axis and the second angled rim is angledposteriorly toward the central longitudinal axis.
 22. The method ofclaim 17, wherein an inside diameter of the second angled rim is lessthan an inside diameter of the first angled rim.